casimersen · Sarepta Theraps Inc · NDA 213026
Amondys 45
Earliest generic entry, as listed
12 Nov 2030
Blocked by patent: US 10287586, US 10781450, US 9228187, US 9758783, US 9758783.
Listed patents · 7 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 10287586 | substance, product | 12 Nov 2030 |
| US 10781450 | use U-3089 | 12 Nov 2030 |
| US 9228187 | substance, product | 12 Nov 2030 |
| US 9758783 | use U-3088 | 12 Nov 2030 |
| US 9758783 | use U-3089 | 12 Nov 2030 |
| US RE48960 | substance, product, use U-3087 | 16 Feb 2029 |
| US RE48960 | substance, product, use U-3088 | 16 Feb 2029 |
Exclusivities · 1 unexpired
| ODE-347 | orphan drug (7 years) | 25 Feb 2028 |
Paragraph IV certifications · 0
No Paragraph IV certification listed by FDA for this drug.
The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.
Event history
No events yet. The first ingestion only records products entering their 12-month window; changes appear from the next Orange Book update.
Products covered · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 213026 · 001 · RLD | solution, intravenous | 100MG/2ML (50MG/ML) | 12 Nov 2030 |
Expired or delisted (1)
- NCE · 25 Feb 2026